A Phase 2 Study of Sitravatinib in Combination with Nivolumab in Patients with Advanced or Metastatic Urothelial Carcinoma (516-003)

Updated on 2 June 2021
tumor cells
platinum-based chemotherapy
advanced urothelial carcinoma
metastatic urothelial carcinoma
urothelial carcinoma
advanced urothelial cancer


This is a study involving an investigational (experimental) drug called sitravatinib, given in combination with the immunotherapy nivolumab (also known as OPDIVO®). 
Sitravatinib is designed to block specific proteins that are thought to cause tumors to grow and to prevent growth of new blood vessels that help cancer tumors to grow and spread.   In addition, research indicates that sitravatinib may help stimulate a patient’s immune system, improving its ability to recognize and attack cancer cells.  
Nivolumab is an FDA approved, prescription drug that belongs to a class of drugs known as checkpoint inhibitors; specifically, nivolumab is an inhibitor of the Programmed Cell Death (or PD 1).  Cancers can have extra signal molecules (PD-L1 molecules) on their surface that make the immune system accept them as normal, helping the cancer cells avoid attack by the immune system.  Nivolumab can block these signal molecules, allowing the immune system to recognize and attack cancer cells.  
This study will evaluate whether the combination of immune system stimulation caused by sitravatinib and improved recognition of tumor cells caused by nivolumab results in more anti tumor activity (tumor shrinkage) than would be expected with either agent used alone.
Patients will be grouped into cohorts based upon the following:
  • Whether or not patients were previously treated with or were ineligible for platinum-based chemotherapy 
  • Whether or not patients were previously treated with a checkpoint inhibitor or another type of immunotherapy
  • Whether or not patients were treated with an antibody-drug conjugate (ADC)
Study cohorts may include 9 - 45 patients depending on the cohort assignment and on how much anti-tumor activity is seen in a cohort.  Up to a maximum of 330 patients across approximately 27 study sites in the United States are expected to participate in this study.  


Sitravatinib oral capsules administered daily in combination with nivolumab administered as 240 mg IV every 2 weeks or 480 mg IV every 4 weeks.
Several laboratory tests will be performed using samples of tumor tissue (archival tissue may be submitted and/or having tumor biopsy performed prior to the study and at 1 timepoint on-study) or blood to understand how and why the drugs may work together in the treatment of urothelial carcinoma.
For further information, please contact Mirati Therapeutic Study Locator Services via e-mail at miratistudylocator@emergingmed.com or via phone 1-844-893-5530 (toll free).

Condition Urothelial Tract Cancer, Urothelial Carcinoma, Urothelial Cancer, Advanced or Metastatic Urothelial CarcinomaAdvanced Urothelial CarcinomaMetastatic Urothelial Carcinoma
Clinical Study IdentifierTX225018
Last Modified on2 June 2021


Yes No Not Sure

Inclusion Criteria

Diagnosis of urothelial carcinoma
Adequate bone marrow and organ function

Exclusion Criteria

Uncontrolled tumor in the brain
Unacceptable toxicity with prior checkpoint inhibitor
Impaired heart function
Clear my responses

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